How We Work

AlvaMed offers an extensive range of medical device consulting services including regulatory, quality and clinical support to meet your needs.

We have considerable experience over the past 14 years in quality and regulatory affairs to ensure QMS elements are effective and efficient. We offer a large library of Quality Manual, SOP and form templates available to help support projects. Moreover, we have helped develop quality management systems for multiple companies, and offer vast clinical affairs support.

AlvaMed is an industry leader in medical device consulting and is comprised of technically savvy quality and regulatory professionals comprising a broad range of complementary skills. The flexibility within our team allows us to quickly adapt our level of support to your changing needs or as you hire your own internal resources. We strive to build long term relationships with our clients by listening to them and then providing “right sized” services and solutions.

A FIRST PROJECT:

All AlvaMed projects are unique to our client’s needs.

Projects range in size from $1,000 to $100,000. Our services are charged either on a

  1.  “Time and Materials” basis at hourly rates ranging between $80 and $270 depending upon seniority; or,
  2.  A “Fixed Fee” monthly fee when we are providing the internal representation of functions within your organization. These range from:
    a. $2,000 per month for document control support; to,
    b. $30,000 per month for ongoing quality assurance, regulatory and clinical affairs support.

We are most comfortable breaking larger efforts into more manageable phases. While we can provide estimates going out a year in advance, we mos t often find it practical to propose and agree on projects with a 3-month duration.

We can start work quickly – often in less than 2 weeks, by following this process:

  1. You have recognized that you have a need for our services.
  2. Click this link and contact us.
  3. We will set a time for an initial business meeting – a “relationship meeting” – to discuss your needs and whether AlvaMed is a good fit for the support you need. Prior to the meeting we usually sign a confidentiality agreement to provide you with the assurance of the protection of your intellectual property. This initial meeting is typically a 30 minute discussion with one of AlvaMed’s principals – Mark Cox or Jon Saltonstall. The objective of the meeting is to verify that forming a business relationship is attractive to both parties.
  4. If agreed, AlvaMed will then arrange a “project meeting” to discuss the technical objectives of the project. Typically an hour meeting, you will meet and discuss the project with the actual project team. The objective of this meeting is to determine the objectives and approach for the project. During this meeting we discuss schedule, budget and any key milestones.
  5. With the output of the “project meeting” AlvaMed creates a formal proposal for the project that, when signed, will serve as our agreement. Most of our projects have a compliance component and in most cases we are required to be an approved supplier. Being ISO 13485 certified and having internal processes that are Part 11 compliance, this process can be completed quickly. Should you be a larger company we are happy to review and agree to a Master Services Agreement.
  6. Once the project is complete a quality representative from AlvaMed will call you to briefly discuss the outcome and quality of our work.

 

REPEAT BUSINESS

More than 90% of our business is repeat business. Having developed a business relationship we can quickly respond to additional or changes needs that you have.

  1. A new proposal can be requested, delivered and approved within a week.
  2. Our team develops an appreciation of your business and products, and this knowledge is leveraged each time we work for you.

AlvaMed meets with prospective clients to understand their potential needs and requirements. After meeting and discussing. AlvaMed develops a proposal based upon your specific needs. Our services range from opinions and reviews to short and long term projects. Proposals provide the objective of our project, the scope of our work and an estimated timeframe for completion. AlvaMed remains in direct contact throughout the entire project and gives updates as we progress on the work.

Please check out our Case Studies to see how AlvaMed approached and tackled a variety of projects for numerous clients.